US11376054B2ActiveUtilityA1

On-demand implant customization in a surgical setting

82
Assignee: STRYKER EUROPEAN OPERATIONS LTDPriority: Apr 17, 2018Filed: Apr 17, 2019Granted: Jul 5, 2022
Est. expiryApr 17, 2038(~11.8 yrs left)· nominal 20-yr term from priority
A61F 2002/3096A61B 2034/108A61B 2034/252A61B 2090/3762A61B 2034/105A61B 90/98A61B 2017/568A61B 17/80A61B 2034/256A61B 17/8863A61B 34/10A61B 2090/376G06F 30/00A61B 2034/102A61B 17/62A61B 17/60A61B 34/25A61F 2/30942
82
PatentIndex Score
4
Cited by
194
References
28
Claims

Abstract

Disclosed herein are apparatuses and methods for intraoperative on-demand implant customization in a surgical setting. An apparatus may include a storage portion, an implant customization portion and an interface. The storage portion may house implant blanks and implant accessories. The implant customization portion may customize the implant blanks. The interface may be configured to receive implant customization information and utilize the same to intraoperatively manipulate the implant blank to a patient-specific implant within a sterile environment. A method to customize an implant in a surgical care environment may include the steps of obtaining information related to the implant location, selecting an implant blank based on the information, and customizing the implant blank in a surgical care setting with a customization apparatus.

Claims

exact text as granted — not AI-modified
The invention claimed is: 
     
       1. An apparatus for customizing an implant comprising:
 a storage portion for housing one or more implant blanks; 
 an implant customization portion for customizing the implant blanks; 
 an implant handler to move the implant blanks from the storage portion to the implant customization portion, and 
 an interface configured to receive implant customization information, 
 wherein the apparatus is configured to be located in a sterile environment such that the implant customization information is used by the customization portion to intraoperatively manipulate the implant blank to a patient-specific implant within the sterile environment, 
 wherein the storage portion, the implant customization portion and the implant handler are disposed within a body of the apparatus. 
 
     
     
       2. The apparatus of  claim 1 , wherein the storage portion and the implant customization portion are sterile such that the implant blanks remain sterile during and after customization. 
     
     
       3. The apparatus of  claim 1 , wherein the implant customization portion includes a bending mechanism such that the implant blank is bent to form the patient-specific implant. 
     
     
       4. The apparatus of  claim 3 , wherein the bending mechanism includes a series of movable elements, a distal end of at least one element configured to translate by an actuator such that the distal ends of the movable elements define a profile of the patient-specific implant. 
     
     
       5. The apparatus of  claim 4 , wherein the bending mechanism includes a first row of movable elements on a first side of the patient-specific implant and a second row of movable elements on a second side of the patient-specific implant. 
     
     
       6. The apparatus of  claim 4 , wherein the bending mechanism includes a translatable frame attached to any of the movable elements and the patient-specific implant. 
     
     
       7. The apparatus of  claim 1 , wherein the implant customization portion includes a cutting mechanism such that the implant blank is cut to form the patient-specific implant. 
     
     
       8. The apparatus of  claim 1 , wherein the implant customization portion includes a bending mechanism and a cutting mechanism such that the implant blank is cut and bent to form the patient-specific implant. 
     
     
       9. The apparatus of  claim 1 , wherein the implant customization information includes CT, X-ray, fluoroscopy or other visualization data of a target body location receiving the implant. 
     
     
       10. The apparatus of  claim 9 , wherein the CT, X-ray, fluoroscopy or other visualization data is obtained by a visualization system located within the sterile environment. 
     
     
       11. The apparatus of  claim 1 , wherein the implant customization information further includes stored database information of target body location. 
     
     
       12. The apparatus of  claim 1 , wherein the interface allows input from an operator to modify the customization information. 
     
     
       13. The apparatus of  claim 1 , wherein the apparatus further includes a display device to display a virtual patient-specific implant generated by the customization information. 
     
     
       14. The apparatus of  claim 1 , wherein the patient-specific implant is a bone plate and the customization information includes virtual bone reduction information to generate a patient-specific bone plate. 
     
     
       15. The apparatus of  claim 1 , wherein the customization information includes shape and dimensional information of the patient-specific implant. 
     
     
       16. The apparatus of  claim 1 , wherein the customization information is derived from a flexible template positioned on a target body location. 
     
     
       17. A method for implant customization in a surgical care environment comprising the steps of:
 obtaining information related to a target body location to receive an implant; 
 selecting an implant blank from a storage portion based on the information; 
 moving the implant blank from the storage portion to a customization apparatus using an implant handler, and 
 customizing the implant blank within the surgical care environment in the customization apparatus to manipulate the implant blank to a patient-specific implant based on the information, 
 wherein the customization apparatus, the storage portion and the implant handler are disposed within a body of an apparatus, the apparatus being located in a surgical care environment such that the customization is performed intraoperatively or preoperatively. 
 
     
     
       18. The method of  claim 17 , wherein the customization apparatus includes a bending mechanism and the step of customizing the implant blank is performed by bending the implant blank with the bending mechanism to generate the patient-specific implant based on the information. 
     
     
       19. The method of  claim 17 , wherein the customization apparatus includes a cutting mechanism and the step of customizing the implant blank is performed by cutting the implant blank with the cutting mechanism to generate the patient-specific implant based on the information. 
     
     
       20. The method of  claim 17 , wherein the customization apparatus includes a bending mechanism and a cutting mechanism and the step of customizing the implant blank is performed by bending and cutting the implant blank by the bending mechanism and the cutting mechanism respectively to generate the patient-specific implant based on the information. 
     
     
       21. The method of  claim 17 , wherein the step of obtaining the information is performed by CT, X-ray, fluoroscopy or other visualization means of the target body location. 
     
     
       22. The method of  claim 17 , wherein the step of obtaining the information comprises the steps of:
 placing a flexible template on the target body location; 
 manipulating the flexible template based on the target body location such that the flexible template corresponds to the patient-specific implant, and 
 communicating shape and dimensional information of the manipulated flexible template to the customization apparatus. 
 
     
     
       23. The method of  claim 17 , wherein the target body location is a fractured bone and the information includes information related to a virtual bone reduction of the fractured bone. 
     
     
       24. The method of  claim 23 , wherein the patient-specific implant is a patent-specific bone plate that corresponds to the virtual bone reduction information. 
     
     
       25. The method of  claim 17 , wherein the step of selecting an implant blank is performed by evaluating the information to minimize customization of the selected implant blank to generate the patient-specific implant. 
     
     
       26. The method of  claim 17 , wherein the step of customization is performed intraoperatively such that the implant blank is manipulated to the patient-specific implant in under 60 minutes. 
     
     
       27. The method of  claim 17 , wherein the customization apparatus is maintained under sterile conditions such that the patient-specific implant generated from the customization apparatus is sterile. 
     
     
       28. The method of  claim 27 , further including the step of receiving the patient-specific implant from the customizing apparatus located in the surgical environment, and implanting the patient-specific on the target body location.

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